Automating Quality6 Syys 2022

Episode 42: Gens & Associates' Quality Benchmark with Katherine Yang-Iott

Welcome to Automating Quality. Mandy Gervasio is your host, and she's on a mission to bring you hot industry topics with her fellow life sciences partners and friends! In today's episode, we will discuss the discoveries of the Quality Benchmark conducted by Gens & Associates in late 2021.

Our guest today is Katherine Yang-Iott. She is a consultant and analyst for Gens and Associates and the study lead for the firm's first Quality-focused benchmark. She's had 2 decades of experience as a scientist and researcher.

Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021.

Key Takeaways

01:32 Introducing today's guest: Katherine Yang-Iott, an Analyst at Gens & Associates

03:07 Katherine introduces Gens & Associates and the context of this study

06:07 What were the key findings of this survey?

08:50 What is a QMS in the perspective of Katherine

11:12 What was the goal of the study in terms of information produced?

14:20 How the pandemic has increased companies' focus on supplier management

20:00 Mandy mentions that CAPA is a quality process that companies still struggle to get right today

21:20 Philippe shares his thoughts on the benchmark's key learnings

22:57 What are the next steps for G&A in the world of quality?

25:15 Mandy thanks our guest and invites listeners to share their feedback

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Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, we discuss a topic key to the heart of most quali...

7 Touko 202415min

Episode 54: Risk Management Tools and Techniques with Michael Tyo

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a di...

6 Helmi 202415min

Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo discusses how warning letters c...

9 Tammi 202418min

Episode 52: Supplier Quality Management w. Mandy Gervasio

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS, and Mand...

28 Marras 202317min

Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio

17 Loka 202320min

Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this very specia...

1 Elo 202316min

Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve

4 Heinä 202316min

Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia

2 Touko 202314min

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